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PF-06863135 is a double-specific antibody, BCMA protein in MM patients high expression of cancer cells, PF-06863135 can be tumor cells on the BCMA protein presented to T cell-specific expression of CD3 protein, which activates the immune system to identify and kill tumor cells.
is designed to give patients higher doses of PF-06863135, resulting in a significant reduction in adverse reactions compared to intravenous dosing.
the main purpose of this study was to assess the safety and toerability of PF-06863135 injections under the skin to determine the maximum to-dosage for patients and to determine the optimal dose of the phase II clinical study.
dose-limiting toxicity was not observed at any measured dose level (80 to 1000 μg/kg per week) during the dose increment period.
73.3% of patients reported cytokine release syndrome (CRS), which was limited to level 1 (56.7%) and level 2 (16.7%).
more than 10% of patients had level 3 or above adverse events (AEs), including lymphocyte reduction (53.3%), neutral granulocyte reduction (26.7%), plate reduction (16.7%) and anemia (16.7%).
effective dose was 80% in 20 patients with a weekly dose of 215 to 1000 μg/kg, of which 6 patients achieved strict complete remission or complete remission, 3 patients achieved good partial remission, and 6 patients achieved partial remission.
at least 1 BCMA targeted treatment before 3 patients reached remission.
maximum dose group (1,000 μg/kg) ORR was 83% (5/6 cases).
these data, the recommended dose for Phase II clinical studies is set at 1,000 μg/kg per week.
multiple myeloma is a type of blood cancer that affects the production of plasma cells in the bone marrow, a blood cell that helps the body fight infection.
latest data available, there are 32,270 new MM cases in the United States each year, and there are about 160,000 cases worldwide.
treatments are improving, they are still incurable.
patients with a medium survival of about 5 years, most of them after 4 lines and above treatment.
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